Land: USA
Språk: engelska
Källa: NLM (National Library of Medicine)
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O), SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)
ATOMY CO LTD
DENTAL
OTC DRUG
OTC monograph final
ATOMY TOOTHPASTE - SODIUM FLUORIDE PASTE, DENTIFRICE ATOMY CO LTD _Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they_ _comply with applicable regulations and policies. FDA has not evaluated whether this product complies._ ---------- ATOMY TOOTHPASTE DRUG FACTS ACTIVE INGREDIENTS Sodium Monofluorophosphate 0.16% Sodium Fluoride 0.1% USES aid in the prevention of dental cavities DIRECTIONS Adults and children 2 years of age and older ;Brush teeth throughly preferably after each meal or at least twice a day or as directed by a dentist or doctor. Children under 6 years ;To minimize swallowing, use a pea-sized amount and supervise brushing until good habits are established. Children under 2 years ;Consult a dentist or doctor. WARNINGS Keep out of reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away. ATOMY TOOTHPASTE 200g/7.05 fl.oz ATOMY TOOTHPASTE sodium fluoride paste, dentifrice PRODUCT INFORMATION PRODUCT T YPE HUMAN OTC DRUG ITE M CODE (SOURCE ) NDC:52257-10 0 3 ROUTE OF ADMINISTRATION DENTAL ATOMY CO LTD ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRE NG TH SO DIUM FLUO RIDE (UNII: 8 ZYQ1474W7) (FLUORIDE ION - UNII:Q8 0 VPU40 8 O) SODIUM FLUORIDE 0 .2 g in 20 0 g SO DIUM MO NO FLUO RO PHO SPHATE (UNII: C8 10 JCZ56 Q) (FLUORIDE ION - UNII:Q8 0 VPU40 8 O) SODIUM MONOFLUOROPHOSPHATE 0 .32 g in 20 0 g PACKAG ING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NDC:52257-10 0 3-2 1 in 1 BOX 1 NDC:52257-10 0 3-1 20 0 g in 1 TUBE MARKETING INFORMATION MARKE TING CATE GORY APPLICATION NUMBE R OR MONOGRAPH CITATION MARKE TING START DATE MARKE TING END DATE OTC mo no graph final pa rt355 0 5/25/20 10 LABELER - AT OMY CO LT D (631154601) Revised: 5/2010 Läs hela dokumentet